Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2656-2015 | Class II | URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical... | Customed, Inc | NWO | |
| Z-2655-2015 | Class II | SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surgical... | Customed, Inc | JOL | |
| Z-2654-2015 | Class II | SHOULDER PACK 3/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJH | |
| Z-2653-2015 | Class II | REEMPLAZO DE RODILLA Y CADERA 2/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OJH | |
| Z-2652-2015 | Class II | SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OJH | |
| Z-2651-2015 | Class II | TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgical... | Customed, Inc | LRO | |
| Z-2650-2015 | Class II | FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2649-2015 | Class II | OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OFA | |
| Z-2648-2015 | Class II | SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJH | |
| Z-2647-2015 | Class II | EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJH | |
| Z-2646-2015 | Class II | HIP AND KNEE REPLACEMENT 3/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OJH | |
| Z-2645-2015 | Class II | ARTHROSCOPY PACK 3/Cs Used by medical staff to perform surgical procedures and patient... | Customed, Inc | HRX | |
| Z-2644-2015 | Class II | GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform... | Customed, Inc | FYA | |
| Z-2643-2015 | Class II | GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform... | Customed, Inc | HRX | |
| Z-2642-2015 | Class II | GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform... | Customed, Inc | FYA | |
| Z-2641-2015 | Class II | O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OKV | |
| Z-2640-2015 | Class II | LAPAROTOMY PACK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | LRO | |
| Z-2639-2015 | Class II | SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical... | Customed, Inc | OJH | |
| Z-2638-2015 | Class II | MINOR PACK 4/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | LRO | |
| Z-2637-2015 | Class II | UROLOGY SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2636-2015 | Class II | EENT PACK I (1) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and... | Customed, Inc | OGR | |
| Z-2635-2015 | Class II | (1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and... | Customed, Inc | KKX | |
| Z-2634-2015 | Class II | EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical... | Customed, Inc | HRX | |
| Z-2633-2015 | Class II | EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | OGR | |
| Z-2632-2015 | Class II | LUMBAR PACK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | LRO | |
| Z-2631-2015 | Class II | CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical... | Customed, Inc | KKX | |
| Z-2630-2015 | Class II | LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical... | Customed, Inc | FDE | |
| Z-2629-2015 | Class II | NEURO PACK 2/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJG | |
| Z-2628-2015 | Class II | EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | OGR | |
| Z-2627-2015 | Class II | SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | LRO | |
| Z-2626-2015 | Class II | SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OJH | |
| Z-2625-2015 | Class II | LITHOTOMY PACK 10/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | LRO | |
| Z-2624-2015 | Class II | FEMORAL PACK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | HRX | |
| Z-2623-2015 | Class II | KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | HRX | |
| Z-2622-2015 | Class II | ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures... | Customed, Inc | OEQ | |
| Z-2621-2015 | Class II | GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform... | Customed, Inc | EFQ | |
| Z-2620-2015 | Class II | GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical... | Customed, Inc | EFQ | |
| Z-2619-2015 | Class II | GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform surgical... | Customed, Inc | EFQ | |
| Z-2618-2015 | Class II | ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OEQ | |
| Z-2617-2015 | Class II | SHOULDER PACK CUSTOMED 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OJH | |
| Z-2616-2015 | Class II | HIGADO Y PANCREA 2/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | LRO | |
| Z-2615-2015 | Class II | ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical... | Customed, Inc | KKX | |
| Z-2614-2015 | Class II | OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJK | |
| Z-2613-2015 | Class II | HIP ORTHO. PACK 3/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | OJH | |
| Z-2612-2015 | Class II | OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and patient... | Customed, Inc | OJK | |
| Z-2611-2015 | Class II | MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical procedures... | Customed, Inc | KKX | |
| Z-2610-2015 | Class II | LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and... | Customed, Inc | LRO | |
| Z-2609-2015 | Class II | MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical... | Customed, Inc | LRO | |
| Z-2608-2015 | Class II | UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | KNX | |
| Z-2607-2015 | Class II | UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care... | Customed, Inc | KNX |